The following data is part of a premarket notification filed by Orsense Ltd with the FDA for Pulse Oximeter Nbm-200.
| Device ID | K142209 |
| 510k Number | K142209 |
| Device Name: | Pulse Oximeter NBM-200 |
| Classification | Oximeter |
| Applicant | ORSENSE LTD 17 Ha'Mefalsim St. Kiryat Arie Petah-tikva, IL 49003 |
| Contact | Aharon Weinstein |
| Correspondent | Mark A Heller GOODWIN/PROCTER LLP 901 NEW YORK AVE N.W. Washington, DC 20001 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2015-01-16 |
| Summary: | summary |